NDC 54796-004 Disinfectanttablets

Disinfectant Tablets

NDC Product Code 54796-004

NDC CODE: 54796-004

Proprietary Name: Disinfectanttablets What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Disinfectant Tablets What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Shape: BULLET (C48335)

NDC Code Structure

  • 54796 - Wuxi Youjie Technology Co. Ltd

NDC 54796-004-01

Package Description: 400 g in 1 BOTTLE

NDC Product Information

Disinfectanttablets with NDC 54796-004 is a a human over the counter drug product labeled by Wuxi Youjie Technology Co. Ltd. The generic name of Disinfectanttablets is disinfectant tablets. The product's dosage form is granule and is administered via extracorporeal form.

Labeler Name: Wuxi Youjie Technology Co. Ltd

Dosage Form: Granule - A small particle or grain.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Disinfectanttablets Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • 1,3-DIBROMO-5,5-DIMETHYLHYDANTOIN 200 g/400g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM SULFATE (UNII: 0YPR65R21J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wuxi Youjie Technology Co. Ltd
Labeler Code: 54796
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-28-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Disinfectanttablets Product Label Images

Disinfectanttablets Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Dosage & Administration

Store in a cool place.

Inactive Ingredient

SODIUM SULFATE

SODIUM CHLORIDE

Indications & Usage

Enmironmental suface: 1 tablet: 1L 450mg/L 10 mins Soaking and spraying.General object surface: 1 tablet: 1L 450mg/L 10mins Soaking, rinsing andwashing with dean water after cleaning and disinfedion.Fabrics: 1 tablet: 1L 450mg/L 10 mins Soaking, rinsing.Swimming pool and other large water bodies: 1 tablet: 1L 3mg/L 10 mins water spraying.

Otc - Active Ingredient

1,3-DIBROMO-5,5-DIMETHYLHYDANTOIN

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Disinfection

Sterilization

Warnings

1. Disinfectants for extemal use should not be taken orally, and keep it out of children's reach.

2. It cannot be used with iodine or peroxide.

3. If there is a small amount of precipitation or floating during dissolution, itcan be properly strred without affecting normaluse.

4. When itis used for disinfection of large water body, it can be pre-dissolved in the container before sprinkling.

5. The product is corrosive to carbon steel and copper, so it should be used carefully for disinfection of such metal products.

6. Store in a cool place.

* Please review the disclaimer below.